NCT03529188

Brief Summary

Type 1 diabetes usually appears brutally in children or young adults. While many factors of poor glycemic balance have been identified in the literature (age, socio-cultural and socio-economic level, family structure, adherence etc.), it turns out that hypoglycemia is the most common acute complications. It would be an important physiological and psychological barrier for the patient and his parents to manage this diabetes, the latter seeking to keep the blood glucose levels above the objectives in order to avoid the occurrence of a hypoglycemia, especially nocturnal. If there is a questionnaire currently validated as a tool to measure the fear of hypoglycemia (HFS, Hypoglycemia Fear Survey is available in three versions: L'HFS-Child (HFS-C) for children over 6 years old, HFS-Parents of Young children ( HFS-PYC) for parents of young children (under 8 years of age) and HFS-Parents (HFS-P)) for parents of children over 8 years of age, on the other hand, there are no French and no French studies have evaluated the prevalence and impact of the fear of hypoglycemia in French patients with type 1 diabetes. It is therefore essential to use a reliable and valid tool to identify patients affected by the fear of hypoglycemia, which can be an obstacle to improve glycemic control and to an optimum quality of life. Having a tool in French and validated on the scientific level would allow to propose adapted therapeutic treatments (psychological follow-up, individual or collective sessions of therapeutic education, material assistance (sensor of blood glucose, pump with insulin stop...) In order to both improve metabolic balance while increasing the quality of life of patients by lowering secondary anxiety to hypoglycemia

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 3, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

March 13, 2018

Last Update Submit

October 5, 2020

Conditions

Diabetes Type 1

Keywords

Diabetes type 1Child ans teenagerFear of Hypoglycaemia

Outcome Measures

Primary Outcomes (3)

  • HFS-Child score,

    Change of Behaviour adopted by the patient in order to avoid the occurrence of hypoglycemia and worry about low blood sugar

    Month 0

  • HFS-PYC score

    Change in Anxiety related to the phenomenon of hypoglycemia

    Month 0, Month 3 (+/- 30 days)

  • HFS-Parent score

    Change of Behaviour adopted by the parent in order to avoid the occurrence of hypoglycemia

    Month 0, Month 3 (+/- 30 days)

Secondary Outcomes (3)

  • Questionnaire Survey "children "

    Month 0, Month 3 (+/- 30 days)

  • Questionnaire Survey "parents "

    Month 0, Month 3 (+/- 30 days)

  • HbA1C

    Month 0, Month 3 (+/- 30 days)

Eligibility Criteria

Age2 Years - 18 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmale or female
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Child and teenager with Type 1 diabetes defined by an hyperglycemia higher than 2g/l, polyuria, polydipsia and positive antibody.

You may qualify if:

  • Age between 2 and 18 years
  • Type 1 diabetes defined by an hyperglycemia higher than 2g/l, polyuria, polydipsia and positive antibody
  • insulin-treated type 2 diabetes by daily injections or insulin pump

You may not qualify if:

  • Trouble to read
  • Trouble to understand
  • Trouble to answer to the questionnaire
  • Opposition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHRU de Brest

Brest, 29609, France

RECRUITING

Centre Hospitalier de Bretagne Sud

Lorient, 56322, France

RECRUITING

Hôpital Universitaire Robert-Debré

Paris, 75 935, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Chantal METZ

CONTACT

02 29 02 00 04chantal.metz@chu-brest.fr

Chantal METZ

CONTACT

chantal.metz@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2018

First Posted

May 18, 2018

Study Start

August 3, 2018

Primary Completion

December 3, 2020

Study Completion

December 3, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement

Locations

FR(3)